Betadine

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Betadine
100 mg/ml (10%) solution for skin
Povidone iodine
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If you feel unwell, contact your doctor.

Table of contents of the leaflet:

1. What Betadine 100 mg/ml solution for skin is and what it is used for
2. Important information before using Betadine 100 mg/ml solution for skin
3. How to use Betadine 100 mg/ml solution for skin
4. Possible side effects
5. How to store Betadine 100 mg/ml solution for skin
6. Contents of the pack and other information

1. What Betadine 100 mg/ml solution for skin is and what it is used for

Betadine 100 mg/ml solution for skin is intended for external use only.
It acts against a wide range of microorganisms (bactericidal, fungicidal, selectively virucidal, and
antiprotozoal).
The product is indicated for skin disinfection prior to injection, blood collection, needle biopsy, transfusion,
disinfection of skin and mucous membranes before surgical procedures, aseptic wound care,
treatment of bacterial and fungal infections, and for total or partial patient disinfection before surgery.

2. Important information before using Betadine 100 mg/ml, cutaneous solution

When not to use Betadine 100 mg/ml, cutaneous solution

• if the patient is allergic to iodine or povidone, or to any of the other components of this medicine (listed in section 6),
• if the patient has been diagnosed with hyperthyroidism or other overt thyroid disorders,
• if the patient has dermatitis herpetiformis (Duhring's disease),
• if the patient has renal failure,
• before and after radioactive iodine treatment for hyperthyroidism, or diagnostic tests involving radioactive iodine.

Warnings and precautions
Before starting treatment, discuss this with your doctor or pharmacist.
In patients with latent thyroid dysfunction (especially in elderly individuals),
use of this medicine for longer than 14 days or on large skin surfaces
(over 10% of body surface area) is permitted only if decided by a physician, after
careful consideration of expected benefits and potential risks. In such cases, the physician
should monitor for early signs of hyperthyroidism and assess thyroid function, even after
discontinuation of treatment (for up to 3 months).
During surgical preparation, pooling of the solution under the patient should be avoided. Prolonged
exposure to the medicine may cause irritation or, less frequently, severe skin reactions. Chemical
skin burns may occur due to pooling of the liquid. In case of skin irritation, contact dermatitis, or hypersensitivity to the medicine, treatment should be discontinued.
Do not heat the medicine before application. Keep out of reach of children.
Patients with goitre, thyroid nodules, or other non-toxic thyroid disorders are at risk of developing
hyperthyroidism after administration of large amounts of iodine. In these patients, prolonged use or
application over large skin areas should not be performed unless deemed necessary by a physician. The physician should monitor for early signs of hyperthyroidism and assess thyroid function.
Particular caution is required when using this medicine regularly in patients with pre-existing
renal impairment.
Avoid using Betadine 100 mg/ml, cutaneous solution, in patients receiving lithium therapy.
Use of this medicine may reduce iodine uptake by the thyroid gland, which may interfere with
the results of certain diagnostic tests and make some procedures difficult (e.g. thyroid scintigraphy,
protein-bound iodine measurement, diagnostic procedures using radioactive iodine), thereby
preventing planned treatment of thyroid disorders with radioactive iodine. After discontinuation of
this medicine, such tests should not be performed for at least 1–4 weeks.
The oxidizing effect of this medicine may lead to false-positive results in various diagnostic tests
(e.g. toluidine and guaiac resin tests for haemoglobin and glucose in stool and urine).
The oxidizing properties of the medicine may cause corrosion of metals, whereas plastics and synthetic materials are generally resistant to povidone-iodine. Reversible staining of certain textile materials (e.g. clothing) may occur.
The medicine can be easily removed from textiles and other materials with warm water and soap. For stubborn stains, an ammonia solution or sodium thiosulfate solution may be used.
The dark brown colour of the medicine indicates its efficacy. If the colour becomes less intense, this indicates reduced antimicrobial activity. Exposure to light and temperatures above 40°C accelerate degradation of the medicine. The medicine has antibacterial activity at pH between 2 and 7.
Avoid contact with the eyes. If the medicine gets into the eyes, open the eyelids and rinse the eyes thoroughly with a large amount of running water for 10–15 minutes. The patient should be examined by an ophthalmologist.

Children and adolescents
In newborns and infants up to 6 months of age, this medicine should be used only if prescribed by a physician in cases of confirmed diagnosis and strict indications for povidone-iodine use. Thyroid function should be monitored.
Newborns and infants up to 6 months of age are at risk of developing hypothyroidism after administration of large amounts of iodine. Therefore, use of this medicine in newborns and infants up to 6 months of age should be limited to the absolute minimum due to significant penetration of the medicine through the skin into the body and increased sensitivity to iodine.
The child must be strictly protected from ingesting the medicine.

Betadine 100 mg/ml, cutaneous solution and other medicines
Inform your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
Concurrent use of this medicine with hydrogen peroxide, enzymatic wound preparations containing silver or taurolidine, or other antiseptics may result in mutual reduction of efficacy.
This medicine must not be used simultaneously with mercury-containing preparations due to the risk of forming a corrosive compound of iodine and mercury.
If this medicine is applied to the same or adjacent area of skin simultaneously or shortly after antiseptic preparations containing octenidine, temporary skin discoloration may occur.
Reactions with proteins and unsaturated organic complexes may occur, which may require higher doses of this medicine (povidone-iodine) to compensate.
Chronic use of this medicine, especially over large skin areas, should be avoided in patients receiving lithium therapy.
This medicine should not be applied to the skin simultaneously with other medicinal products having reducing, acidic properties, or containing alkaloids.

Note
Due to the oxidizing properties of this medicine, contamination with the medicine may lead to false-positive results in certain tests for occult blood in faeces or for blood or glucose in urine.
Use of this medicine may reduce iodine uptake by the thyroid gland, thereby interfering with certain diagnostic tests (e.g. thyroid scintigraphy, protein-bound iodine measurement, tests using radioactive iodine) or preventing treatment of thyroid disorders with radioactive iodine. To obtain accurate results, a sufficiently long interval (1–4 weeks) should be maintained between discontinuation of this medicine and thyroid scintigraphy.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Povidone-iodine has no teratogenic effects.
Use of this medicine during pregnancy and breastfeeding is permitted only if decided by a physician in cases of definite diagnosis and absolute necessity. Thyroid function in both mother and child should be monitored.
Use of this medicine should be limited to a short period of time.
Iodine crosses the placenta and is excreted in breast milk, reaching higher concentrations in milk than in blood.
The infant must be strictly protected from ingesting the medicine.

Driving and operating machinery
This medicine has no effect on the ability to drive or operate machinery.

3. How to use Betadine 100 mg/ml, cutaneous solution

This medicine should always be used exactly as described in this patient information leaflet or as directed by a physician. If in doubt, consult a doctor or pharmacist.

Betadine 100 mg/ml cutaneous solution may be used either undiluted or as a 10% aqueous solution (dilution 1:10) or a 1% aqueous solution (dilution 1:100), depending on the site of application.
The diluted solution should be prepared immediately before use.

For skin disinfection prior to injection, blood sampling, needle biopsy, transfusion or infusion, apply the medicine to healthy, intact skin for 1–2 minutes.

For aseptic wound care, disinfection of mucous membranes, and treatment of bacterial and fungal infections, use the 10% (1:10) solution.

For preoperative patient bathing, use the 1% (1:100) solution. It is best to evenly distribute the diluted solution over the entire body surface and leave it in place for at least 2 minutes, then rinse thoroughly with lukewarm water.

During preoperative preparation, avoid pooling of the solution under the patient. Prolonged exposure to the medicine may cause irritation or, less frequently, severe skin reactions. Chemical skin burns may occur as a result of fluid accumulation.

Use in children
In newborns and infants up to 6 months of age, this medicine should be used only when prescribed by a physician, in cases of confirmed diagnosis and strict indications for its use. Thyroid function should be monitored.

Use of a higher than recommended dose of the medicine
If more medicine has been used than recommended, contact a doctor immediately. After application of very large amounts, symptoms of poisoning may occur, such as anuria, circulatory collapse, laryngeal edema, absence of pulse or weak pulse, pulmonary edema, and metabolic disturbances.
In case of accidental ingestion, seek immediate medical advice from a doctor or hospital.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Uncommon adverse effects (occur in 1 to 10 out of 10,000 people):
Hypersensitivity reactions, contact dermatitis (with symptoms such as redness, small blisters, and itching). If such symptoms occur, discontinue use of the medicine and inform your doctor.
Very rare adverse effects (occur in fewer than 1 out of 10,000 people):
Anaphylactic reaction (a serious allergic reaction causing, among others, breathing difficulties, dizziness, and drop in blood pressure). If such symptoms occur, stop using the medicine immediately and inform your doctor.
Angioedema (a serious allergic reaction causing swelling of the face or throat). If such symptoms occur, stop using the medicine immediately and inform your doctor.
Hyperthyroidism (overactivity of the thyroid gland causing, among others, increased appetite, weight loss, sweating, rapid heartbeat, or restlessness).
Adverse effects with unknown frequency (cannot be estimated from available data):
Hypothyroidism after prolonged or more intensive use of the medicine.
Kidney function disorders.
Chemical skin burn (may occur due to pooling of the medicine under the patient during surgical preparation); electrolyte disturbances, metabolic acidosis, acute kidney failure, abnormal blood osmolality (may occur after application of large amounts of the medicine).
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects allows gathering further information on the safety of the medicine.

5. How to store Betadine, 100 mg/ml, skin solution

Do not store above 25°C.
Shelf life after first opening of the bottle: 3 months, when stored at 5°C - 15°C.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Keep out of sight and reach of children.
Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

1 ml of solution contains 100 mg of povidone-iodine and excipients: glycerol,
nonoxynol 9, citric acid, sodium phosphate, sodium hydroxide, potassium iodate, purified water.
What Betadine 100 mg/ml cutaneous solution looks like and contents of the pack
The medicine is an iodine-coloured solution.
Plastic bottle containing 30 ml of medicinal product in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Greece, the country of export:
Lavipharm A.E.
Agias Marinas
190 02 Peania, Attica
Greece
Manufacturer:
Lavipharm A.E.
Agias Marinas
190 02 Peania, Attica
Greece
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56 Street
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28 Street
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190 Street
91-610 Łódź
Marketing authorisation number in Greece, the country of export: 44734/07/6-5-2008
28328/92/10-05-1995
Parallel import authorisation number: 80/23